PSC Biotech™ has vast experience in the validation of laboratory equipment software in both GMP and GLP environments, recognizing the key part these instruments play in the overall quality and integrity of life sciences data. PSC Biotech™ has excellent background in developing system inventories, performing risk assessments, determining remediation actions, and performing equipment qualification in tandem with software validation. PSC Biotech™ is highly experienced in carefully leveraging vendor packages to minimize additional validation costs. Whether validating existing or new equipment software, PSC Biotech™’s robust, risk-based approach ensures high quality, cost effective solutions.
How We Stay Compliant
PSC Biotech™ ensures that its equipment software validation is compliant with the GMP, GLP, ICH, EMA, 21 CFR Part 11 and other global regulations. Our approach is based on the industry standard GAMP 5 guidelines. PSC Biotech™ places a strong emphasis on maintaining compliance and the validated status of the equipment by ensuring appropriate system specific management procedures and IT/quality management procedures are in place.
What Our Clients are Saying
“I just want to express my appreciation for your impressive AuditUtopia™ program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I do not know how we would have managed without the AuditUtopia™ software. Our Quality staff was able to execute FDA requests rapidly and flawlessly, communicate in real time between the various groups, and all of this resulting in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia™ was a big part of achieving that milestone.”
“This is to certify that PSC Biotech (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”
“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia™ and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”